Kornimate/medical-research-clean huggingface dataset:
early compared with delayed hormone therapy in treating patients with nonmetastatic prostate cancer

Conditions: Neoplasm, Prostate

Summary: objectives i. compare, in a randomized phase iii multi-institutional setting, symptom-free survival time of patients with asymptomatic carcinoma of the prostate (t0-4, n0-2, m0) not suited for local curative treatment who are randomly assigned to immediate vs. delayed endocrine intervention (orchiectomy or luteinizing hormone releasing hormone (lhrh) agonist therapy). ii. compare the overall survival of these two groups of patients. iii. compare the time to first evidence of distant progression (n4 or m1) of these two treatment groups. iv. evaluate the prognostic significance of pretreatment laboratory data and monitor these parameters following endocrine therapy. v. study the prognosis of various sub-groups of patients stratified according to performance status, local tumor extent, nodal status, and choice of endocrine treatment.


Eligibility criteria:
inclusion criteria: * histologically or cytologically proven, newly diagnosed asymptomatic (with the exception of voiding disturbances) carcinoma of the prostate t0-4 n0-2 m0 which is not suitable for local treatment with curative intent (radical prostatectomy, radiation therapy). * all t stages are acceptable (uicc 1982). the stage is determined by rectal palpation. * patients with regional lymph node metastases smaller than 5 cm (n0-2), determined either by ct or ultrasonography, preferable with cytologic confirmation. * life expectancy of at least six months. * who performance status score 0-1. * informed consent. patients must be prepared to undergo an orchiectomy or continuous treatment with a depot lhrh analogue. * continuous follow-up until death if possible. exclusion criteria: * other malignancies diagnosed during the last 10 years, apart from treated basal cell carcinoma of the skin. * prostate cancer known for longer than one month before entering the study. * pain caused by the prostate cancer or its metastases. * any previous treatment for prostate cancer (radical prostatectomy, radiation therapy, endocrine treatment, etc.) note: tur-p for voiding disturbances is allowed at any time and is not an exclusion criterion. * patients with ureteric obstruction caused by local infiltration of prostatic cancer and other evidence of locally advanced disease which could cause fatal complications if untreated (e.g. rectal stenosis, thrombosis of pelvic veins). * patients with palpable or juxtaregional lymph node metastasis (paraaortic, supraclavicular, inguinal, n3-4). * patients with evidence of distant metastases (bone, lung, liver). * age over 80 years. performance status who score 2, 3 and 4 (any reason). * patient who refuses orchiectomy or longterm subcutaneous implants of lhrh analogue in two monthly intervals. expected difficulties with follow-up for any reason.

Keywords: malignant neoplasm of prostate tumor-node-metastasis (tnm) staging regional lymph nodes (n0-2) not suitable for local treatment with curative intent
serum tryptase levels during cardiac surgery, diagnosis and treatment decisions for allergic reactions

Conditions: Protamine Allergy; Protamine Adverse Reaction

Summary: the investigators aim to assess tryptase test efficacy for measuring the allergic response to protamine during cardiac bypass surgery. additionally, the investigators aim to establish a differential diagnosis on the basis of potential allergens or clinical causes.

venous blood samples from cardiac surgery cases will be obtained for tryptase measurement upon admission to the operating room (or) and immediately prior to and 30 min after protamine infusion initiation. a rapid effect-response-based clinical assessment will be made using clinical and laboratory monitoring data for diagnosis and treatment decisions during protamine infusion, which may complicate the recovery from surgery.

Eligibility criteria:
inclusion criteria: * cardiac by-pass cases exclusion criteria: * insulin dependent diabetes * atopy * drug allergy history

Keywords: cardiac by-pass protamine tryptase hypotension anaphylaxis
laparoscopic versus us-guided subcostal tap block after laparoscopic cholecystectomy

Conditions: Cholecystitis; Gallstone

Summary: zaghiyan et al hypothesized that laparoscopic tap was noninferior to us-tap and performed a randomized clinical trial comparing laparoscopic tap, us-tap, and no tap in minimally invasive colorectal surgery. the authors reported that ltap was superior to utap in achieving pain control and minimizing opioid use in the first 24 hours after colorectal surgery. this prospective randomized, controlled trial will be performed to assessed the efficacy of laparoscopic subcostal tap block (lstap) compared to ultrasound-guided subcostal tap (ustap) block after laparoscopic cholecystectomy regarding postoperative pain scores in the first 24-hours after the intervention and analgesic requirements.


Eligibility criteria:
inclusion criteria: * consecutive adult patients of either gender who will undergo laparoscopic cholecystectomy will be recruited to the study. exclusion criteria: * pregnant women * patients who will undergo open cholecystectomy * patients who will need conversion to conventional open cholecystectomy * patients with asa iii classification or higher * patients who will undergo laparoscopic cholecystectomy together with other abdominal interventions.
renin-angiotensin system blockade benefits in clinical evolution and ventricular remodeling after transcatheter aortic valve implantation (rastavi)

Conditions: Transcatheter Aortic Valve Replacemen; Angiotensin-Converting Enzyme Inhibitors

Summary: the investigators aim to demonstrate that ramipril after transcatheter aortic valve implantation has benefits in terms of prognosis, cardiovascular events and ventricular remodeling (mri).


Eligibility criteria:
inclusion criteria: * transcatheter aortic valve implantation due to severe aortic stenosis. * patients must give written informed consent. exclusion criteria: * severe mitral valvulopathy. * reduced left ventricular ejection fraction (lvef \< 40%) with myocardial infarction or dilated cardiomyopathy. * patients on an acei or an arb the last 3 months. * history of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, aceis, arbs, or nep inhibitors as well as known or suspected contraindications to the study drugs. * non-mr-conditional cardiac devices. * estimated gfr \< 30 ml/min. gfr between 30 and 50 ml/min will not receive gadolinium during mri. * systolic blood pressure \< 100 mmhg or diastolic \< 40 mmhg. * pregnant women. * participating in other investigational trial at the time of enrollment

Keywords: cardiovascular events ventricular remodeling
diagnostic value of novel mr imaging techniques for the primary staging and restaging of rectal cancer

Conditions: Rectal Neoplasms; Magnetic Resonance Imaging; Neoplasms Staging

Summary: the purpose of this study is to determine the clinical value of the novel mri-techniques dwi and gadofosveset-enhanced mri for the management of rectal cancer patients.

rectal cancer is a common form of cancer, and the treatment stratification depends on tumour and nodal stage as determined on mri. unfortunately, the information provided by standard t2-weighted mri is not sufficient to accurately assess nodal involvement and tumour response after neo-adjuvant chemoradiotherapy. additional functional information is required for reliable (re)staging. diffusion-weighted imaging and gadofosveset-enhanced mri are two new imaging techniques that have all shown great potential in rectal cancer staging. in order to provide definite evidence there is a need for a multicenter study with a large patient population.

Eligibility criteria:
inclusion criteria: * biopsy proven primary rectal cancer (≤15 cm from the anorectal verge as measured in mri) * age \> 18 years * written informed consent exclusion criteria: * ineligibility to undergo mri (claustrophobia, pacemaker, non-mr compatible surgical implants, metal fragments in the eye) * pregnancy * locally recurrent rectal cancer * a history of severe allergy to contrast agents * ineligibility to receive gadofosveset contrast (history of contrast allergy, impaired kidney function with a glomerular filtration rate \<30 ml/min/1.73m2 * incurable disease due to metastases or co-morbidity

Keywords: nodal imaging restaging
intra-tracheal instillation of budesonide to prevent chronic lung disease

Conditions: Infant, Extremely Premature; Acute Lung Injury; Chronic Lung Disease of Prematurity; Budesonide

Summary: preterm infants are randomized to received either intra-tracheal instillation of budesonide using surfactant as vehicle or a placebo. intra-tracheal instillation of budesonide using surfactant as vehicle would facilitate its delivery to the periphery of the lung and would inhibit lung inflammation and mitigate acute lung injury.

in extremely premature infants who are ventilated there is ongoing lung injury \& lung inflammation. this can perpetuate the need for ongoing ventilation and these infants spend much longer in the hospital. the likelihood of chronic lung disease in this susceptible group is very high and they would need oxygen at home. surfactant instillation has reduced the need for prolonged mechanical ventilation and to an extent the incidence of chronic lung disease (cld). but many infants develop cld and need prolonged oxygen treatment, diuretics and inhaled steroids to suppress the inflammation and obstruction of the airways. some of the severely affected infants need orally administered steroids. the inestigators propose to provide a dose of steroids instilled along with the surfactant in the very first day of life so as to prevent the vicious and ongoing cascade of lung injury and inflammation. as it is a poorly absorbed steroid and as only one or two doses is proposed to be used there is no effects within the body and it works locally within the lung. this is hoped to reduce cld and improve long term outcomes. the population most susceptible to cld is the extreme preterm infant with rds who needs mechanical ventilation soon after birth. one of the groups will receive the surfactant with saline and the other group will receive the surfactant along with topical steroid. the groups will be followed during the hospital stay. survival along with duration of ventilation, duration of hospital stay and oxygen needs are noted. to study the hoped for long term benefits the investigators would note the long term neuro-development - if they were followed as per hospital policy between 18 months and 26 months. intra-tracheal instillation of budesonide using surfactant as vehicle would facilitate its delivery to the periphery of the lung and would inhibit lung inflammation.

Eligibility criteria:
inclusion criteria: * infants born at \ 0.3) exclusion criteria: 1. major congenital defects 2. chromosomal abnormality 3. pneumothorax 4. known surgical disease 5. known or suspected congenital heart disease 6. infant not considered viable by physician 7. severe sepsis / infections 8. likely to be extubated within the next 24 hours
collaborative healthcare professionals approach in monitoring of patient centered outcomes through pathways

Conditions: Heart Failure; Community Acquired Pneumonia; Venous Thromboembolism; Acute Kidney Injury; Asthma

Summary: the aim of this study is to determine if by providing a collaborative, integrated pathway-based healthcare compared to the usual healthcare, whether or not this would be superior in reducing the length of hospital stay across five high frequency /high risk medical diagnoses: acute venous thromboembolism, acute kidney injury, community acquired pneumonia, adult left ventricular heart failure, and asthma.

this study is a pragmatic randomized controlled trial. to date, there is a scarcity of randomized controlled trials looking at pathway-based, patient-centered healthcare versus usual care in several high-risk or high volume diagnoses that account for the vast majority of hospitalizations in medical settings. in this study, the pathway care intervention is a collaborative effort that involves healthcare professionals from multiple departments, including pharmacists, health educators, nurses, social workers, nutritionists, and quality management. for patients allocated to the usual care, these healthcare professionals will deliver standardized care when consulted. for pathway care patients, this collaborative healthcare will be default.

Eligibility criteria:
1. inclusion criteria (overall criteria): * one principle diagnosis * hemodynamic stability 2. inclusion criteria (specific to each diagnosis): acute venous thromboembolism: * new onset / in-patient acute kidney injury: * patients with increased serum creatinine of more than 50% from baseline community acquired pneumonia: * age limit adult left ventricular heart failure: * age limit asthma * acute exacerbation of asthma 3. exclusion criteria (overall criteria): * intensive care unit (icu) patients * pregnancy 4. exclusion criteria (specific to each diagnosis): acute venous thromboembolism: * hemodynamic instability (systolic blood pressure (sbp) less than 90 mmhg or massive pulmonary embolism (pe) * pe patients with an spesi score ≥ 1 acute kidney injury: * critical care patients (icu, coronary care unit, burn units) * stage 4 and 5 chronic kidney diseases * kidney allograft recipients * obstructive uropathy * glomerulonephritis * interstitial nephritis community acquired pneumonia: * intensive care unit (icu) patients * pregnancy adult left ventricular heart failure: * all non-cardiogenic pulmonary edema * patients requiring inotropic agents asthma * patients with chronic obstructive pulmonary disease (copd) and bronchiectasis * severe asthma (peak expiratory flow rate (pefr) less than 40 percent)

Keywords: clinical pathways length of stay patient-centered care pragmatic randomized controlled trial
esp vs esp with pecs

Conditions: Postoperative Pain; Mitral Valve Disease

Summary: patients scheduled for minimally invasive mitral valve repair. each patient will be treated with intravenous (i.v.) oxycodone - patient-controlled analgesia (pca). patients will be allocated to one of the groups: erector spinae plane (esp) block or eps with pectoral fascia (pecs) block.

only patients who are qualified for an elective procedure of mitral valve replacement may participate in the study. each patient will be anesthetized generally. the same drugs will be used in each stage of anesthesia. the induction: etomidate, remifentanil, rocuronium, scolina as required. the maintenance: sevoflurane, remifentanil, rocuronium. the emergence: oxygen, sugammadex or neostigmine a required. patients will be randomly allocated to one of two groups: esp or pecs. among the patients from esp group will have esp blockade before the induction of general anesthesia. esp blockade will be performed under ultrasound control. a single-shot technique will be used with 0.375 % solution of ropivacaine: 0.1 ml per patient kg. the maximum dose is 20 ml. patients from pecs group will receive esp block and pecs i and ii type block with 0.375 % solution of ropivacaine (up to 20 ml of local anesthetic). each patient, before the end of surgery, will be administered i.v. 0.1 mg of oxycodone. pca with oxycodone (1mg/ml) will be utilized during the postoperative period: 7-minute interval. this is standard protocol in the investigator's department. only patients who are successfully awakened after the procedure may participate in the study. the pain intensity will be assessed with visual-analogue scale (vas) at 2, 4, 8, 12 and 24 hour after the end of anesthesia. the total consumption of oxycodone will be also monitored.

Eligibility criteria:
inclusion criteria: * scheduled mitral valve replacement surgery * obtained consent exclusion criteria: * allergy to oxycodone and local anesthetics * depression, antidepressant drugs treatment * epilepsy * usage of painkiller before surgery * addiction to alcohol or recreational drugs * prolonged postoperative ventilation (over 2 hours)

Keywords: erector spinae plane blockade pectoral fascia block patient control anlagesia mitral valve replacement
avs after 1mg dst to determine subtype in pa

Conditions: Primary Aldosteronism

Summary: to compare the effect of different procedures of avs(after 1mg dst or not) in determining the subtypes and long-term outcomes of pa

all paticipants will be randomly divided into 1mg dst group(intervention group,n=43) and placebo group(control group,n=43) and to determining the subtypes and to compare the long-term outcomes of patients with pa.

Eligibility criteria:
inclusion criteria: 1. age 18 or above, male or female, with legal capacity; 2. patients who diagnosed as primary aldosteronism and willing to surgery exclusion criteria: 1. pregnant or lactating women 2. patients with a history of malignant tumors or complicated with severe heart disease, egfr\<30ml/min/1.73m2, severe anemia (hb\<60g/l), stroke or acute coronary syndrome within 3 months, severe liver disease 3. having contraindications or refusal to undergo avs or unilateral adrenalectomy, or allergy to acth; 4. pa combined with cushing syndrome (including subclinical cushing); or considering glucocorticoid-suppressible aldosteronism (gra) or adrenocortical carcinoma;

Keywords: primary aldosteronism adrenal venous sampling
effect of breather in copd patients with intermittent claudication

Conditions: COPD; PAD

Summary: the aim of this study to show the effect of breather on ventilatory and vascular function in copd patient with intermittent claudication.

recent researches show that copd patients have risk of developing peripheral arterial disease (pad) which represented on patient by intermittent claudication inspiratory muscle trainer as the breather device show increasing in inspiratory muscle strength and endurance; reduction of dyspnea; and improving of exercise tolerance . because of all this things this study tends to show the effect of the breather on ventilatory and vascular function in copd patient with intermittent claudication.

Eligibility criteria:
inclusion criteria: * sixty male patients with diagnosed with grade i and grade ii copd their ages ranged between 55-60years * all patients will be clinically and medically stable when attending the study. * body mass index (bmi) is 18.5 to 24.9 kg/m2. * history of unilateral exertional leg pain, * ambulation during a graded treadmill test limited by leg pain consistent with intermittent claudication (stage ii of the fontaine classification of pad), * and an ankle-brachial index (abi) of 0.90 or lower at rest or 0.73 or lower after exercise. exclusion criteria: * cardiovascular insufficiency, * recent myocardial infarction, * heart failure, * arrhythmia, * dvt, * intracranial hypertension, * pneumonia, * kidney failure, * fractures, * uncooperative patients, * cognitive impairment preventing a patient from participation in exercises.
seoul national university prospectively enrolled registry for prostate cancer with active surveillance

Conditions: Prostate Cancer

Summary: in this study, the investigators aim to establish the prostate cancer active surveillance prospective cohort in our institution, and finally investigate the 5 year rates of reclassification during active surveillance as the primary endpoint of the current study.

prostate cancer (pca) remains one of the most commonly diagnosed malignancies in men worldwide. early diagnosis and definitive therapy seem to improve oncological outcomes in men with high-risk disease, but significant concerns exist in terms of the overdiagnosis and overtreatment of patients with lower-risk tumors. in this context, active surveillance (as) has recently emerged as a alternative treatment strategy in pca patients with low risk cancers. however, published data are based on western population with different protocol, and therefore; well-controlled data with well-organized and prospective cohort are urgently needed in korean patients with low-risk pca because korean patients have significantly different tumor characteristics compared to western patients. here, the investigators have a plan to establish the seoul national university enrolled registry for prostate cancer with active surveillance, and finally provide the concrete evidence for the clinical outcomes of active surveillance program as the primary therapeutic strategy for low-risk pca in korean men.

Eligibility criteria:
inclusion criteria: 1. men \< 80 years 2. pathologically proven adenocarcinoma of the prostate by transrectal prostate biopsy ≥ 10 cores 3. pre-bx psa ≤ 10ng/ml 4. psa density \< 0.15ng/ml/ml 5. clinical stage t1-2a 6. biopsy gleason score ≤ 6 7. no. of positive cores ≤ 2 8. maximum cancer involvement in any one core ≤ 20%. 9. no pirads 5 lesion on multiparametric prostate mri (1.5t or 3t) 10. participants must be willing to attend the follow-up visits - t1a-b disease should be confirmed by systematic trus-bx ≥ 10 cores exclusion criteria: 1. a former therapy for prostate cancer.

Keywords: low-risk prostate cancer active surveillance pathologic reclassification
a study of a166 versus trastuzumab emtansine (t-dm1) in patients with her2-positive unresectable or metastatic breast cancer previously treated with trastuzumab and taxane therapy

Conditions: HER2-positive Breast Cancer

Summary: evaluation of the efficacy of a166 versus trastuzumab emtansine (t-dm1) in patients with her2-positive unresectable or metastatic breast cancer previously treated with trastuzumab and taxane therapy

this study will evaluate the efficacy of a166 versus trastuzumab emtansine (t-dm1) in patients with her2-positive unresectable or metastatic breast cancer previously treated with trastuzumab and taxane therapy to further evaluate the efficacy of a166 versus t-dm1 in patients with her2-positive unresectable or metastatic breast cancer, based on effectiveness endpoints including: overall survival (os) progression-free survival (pfs) as assessed by investigators objective response rate (orr), disease control rate (dcr), duration of response (dor), and clinical benefit rate (cbr) assessed by both blinded independent central review (bicr) and investigators. to assess the safety profile of a166 for injection in patients with her2-positive unresectable or metastatic breast cancer. to evaluate the immunogenicity of a166 for injection in patients with her2-positive unresectable or metastatic breast cancer. to characterize the pharmacokinetic (pk) profile of a166 for injection in patients with her2-positive unresectable or metastatic breast cancer.

Eligibility criteria:
inclusion criteria: 1. male or female patient ≥ 18 years and ≤ 75 years when signing the informed consent form. 2. breast cancer patients by histopathology and/or cytology documented. 3. disease progression after receiving a trastuzumab-based regimen (or a commercially available trastuzumab biosimilar or inetetamab) in the advanced or metastatic setting, or disease progression/recurrence within 12 months during or after (neo)adjuvant therapy (with a trastuzumab-based regimen or commercially available trastuzumab biosimilar). 4. have previously received taxanes. 5. patients must have experienced disease progression or intolerance during or after the most recent treatment prior to randomization. 6. at least one measurable lesion according to recist 1.1 criteria exclusion criteria: 1. previous treatment with a166 or any her2-targeted antibody-drug conjugate (adc) with a microtubule inhibitor payload. 2. known history of severe hypersensitivity to other monoclonal antibodies, or allergy to a166 , t-dm1 (trastuzumab emtansine) or their components. 3. permanent discontinuation of trastuzumab or its biosimilars due to any toxicity in prior treatments. 4. presence of severe corneal epithelial disease at baseline; or inability to perform daily activities without contact lenses. 5. presence of spinal cord compression or clinically active central nervous system (cns) metastases. 6. other conditions considered by the investigator to make the patient unsuitable for participation in the study